On November 17, 2017 PledPharma AB ("PledPharma") (STO: PLED) and Solasia Pharma K.K. ("Solasia") (TSE: 4597) reported that they have entered a license agreement pertaining to the clinical development and commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan (Press release, Solasia, NOV 17, 2017, View Source [SID1234532512]).
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Under the terms of this agreement, PledPharma grants exclusive development and commercialization rights to PledOx in the territories mentioned and Solasia will pay upfront, development, regulatory and sales milestones of up to ~USD 83 million (SEK 700 million)*. In addition, Solasia will pay industry standard royalty rates on sales applicable for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients subject to regulatory consultations.
The license agreement is initially focused on the use of PledOx as prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The agreement with Solasia facilitates an expansion of the recently announced global Phase III-program for PledOx with Asian patients, subject to regulatory consultations, aiming to gain sufficient documentation for regulatory approvals in the major Asian markets. In addition, a Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, tolerability and pharmacokinetics will be conducted. Following potential regulatory approvals, Solasia will be responsible for the commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.
"We are very excited to announce our partnership with Solasia – an ideal partner during the development, regulatory process and commercialization of PledOx in this very important region. The collaboration will ensure an optimized expansion of the Phase III program to include Asian patients, aiming at further realising the global commercial potential of our drug candidate," said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.
"We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during the remaining clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets," said Yoshihiro Arai, President and Chief Executive Officer, Solasia.
As PledPharma announced earlier in November, following interactions with the regulatory authorities, EMA and FDA, the company has finalized the design of the global Phase III program for the drug candidate PledOx. The Phase III studies are anticipated to be initiated at the end of 2017 with top line results expected during 2020.
* The total value of upfront and milestone payments is up to JPY 9.3 billion. The amount given in USD and SEK is subject to exchange rate.
Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00 CET where PledPharma will provide a company update and an overview of the license agreement with Solasia. The event will be live streamed from Redeyes website www.redeye.se. After the event, the presentation will be available on PledPharma’s website.